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Persyst 14 Review and Analysis Software

Persyst Development Corp · Model P14 · UDI-DI 00869732000128

OMBOMAOLT Prescription
1
510(k) clearances
36
Adverse events (1 deaths)
1
Recalls
13
Facilities

Description

Persyst 14 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.

Recalls

DateFirmReason
2021-12-02Natus Neurology DBA Excel Tech., Ltd. (XLTEK)Tile kits that allow one to install and situate a video camera within a patient environment are not fitting properly in some domestic institution ceiling tile grids that have a thi

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.